An interventional study of Cancer Pain 101 and Pharmacotherapy Informational Packet in Cognitive Coping and Cancer, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Health services research
The purpose of this study is to implement a healthy, non-invasive therapeutic alternative for managing cancer-related pain in chronic cancer patients (Cancer Pain 101). This pilot trial will investigate the feasibility and effectiveness of implementing this approach through a single session, with the goal of helping patients improve their pain control and pain-related quality of life.
This study is a pilot trial designed to assess the feasibility and efficacy of a single-session cognitive behavioral therapy for pain (CBT) intervention integrated with pharmacotherapy education. Specifically, the study will implement a 90-minute, single-session intervention combining CBT and pharmacotherapy education to help patients self-manage their chronic cancer pain and improve their overall quality of life.
The trial will consist of three aims. Aims 1 and 2 will begin with the pilot trial, Cancer Pain 101. This single-session intervention will assess the feasibility and acceptability of delivering a traditional CBT-based intervention to patients with chronic cancer pain. For Aim 2, the investigator will implement Cancer Pain 101, which combines traditional CBT with pharmacotherapy education, as a behavioral intervention to assess its potential benefits on patients' pain management and quality of life.
For Aim 3, a randomized pilot trial will be conducted to further assess the feasibility of Cancer Pain 101 as an alternative approach to traditional CBT. Participants will be randomized to one of two cohorts (Cohort A or Cohort B). Participants randomized to Cohort A will follow the same process as Aim 1 and will attend a single-session Cancer Pain 101 intervention class. Participants randomized to Cohort B will serve as the control group and will receive an educational packet containing cancer pain and pain-related CBT educational materials from the American Cancer Society (ACS).
Participants in both cohorts will be asked to complete questionnaires to assess their experiences with the intervention or educational materials, as well as changes in pain management and quality of life over the course of the study.
The surveys administers are Pain Catastrophizing Scale (PCS), Pain Self-Efficacy (PSEQ), System Usability Scale (SUS), and Patient Reported Outcome Measurement Information System (PROMIS) to measure patients mood and sleep. The PCS scale is a 13-item self report measure assessed on a 5-point Likert scale 0= Not at all and 4= All the time. The Pain Self-Efficacy scale is a 10-item self report measure of a 7-point Likert scale 0= Less self-efficacy and 6= More self-efficacy. The System Usability Scale is measured on a 5-point Likert scale. PROMIS is a short answer form measured on a 5-point Likert scale. Higher scores indicate higher symptom severity.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 70 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
During the pilot trial, 60 evaluable patients with chronic cancer-related pain will participate in a 90-minute Cancer Pain 101 class focused on behavioral, non-invasive strategies for managing cancer-related pain. Surveys will be completed at baseline and at 2- and 4-week follow-ups. The first outcome will assess the feasibility, acceptability, and perceived usefulness of the intervention. For the second outcome, researchers will use data collected during Aim 1 to examine changes in pain severity, opioid use, pain management, and quality of life compared with baseline measures. The goal is to determine whether participation in Cancer Pain 101 is associated with improved pain control, reduced opioid use, and improved pain-related quality of life.
Other: Cancer Pain 101
Aim 3 of this trial will serve as a randomized pilot trial consisting of two cohorts and will include 60 evaluable patients total amongst the two cohorts. Participants randomized to Cohort A will attend a 90-minute Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life.
Other: Cancer Pain 101
Cohort B will serve as the control group. Patients randomized to this cohort will receive an informational packet containing educational materials on cancer-related pain from the American Cancer Society (ACS). Participants in Cohort B will not attend the Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life.
Other: Pharmacotherapy Informational Packet
This is a 90-minute virtual class led by the Principal Investigator (PI) and the investigational team. The class will cover all six traditional pain-focused cognitive behavioral therapy (CBT) modules referenced in the study protocol. Due to the limited session time, all educational materials and references used during the class are standard-of-care resources.
Patients randomized to Cohort B will receive a informational packet of cancer-pain educational materials provided by the American Cancer Society.
Percentage of Patients Who engage in Cancer Pain 101 intervention attendance.
The primary aim of this study is to determine the feasibility of the Cancer Pain 101 behavioral intervention. Feasibility will be assessed based on several measures, including primarily the proportion of patients who attend the telehealth Cancer Pain 101 intervention, in addition to time to accrual, participation rates, and survey completion rates. Feasibility will be considered demonstrated if more than 70% of enrolled patients participate in the telehealth intervention.
Time frame: 1 Year
Percentage of Patient Who reported acceptability of The Cancer Pain 101 Intervention.
Acceptability will be assessed using participant questionnaire responses. The intervention will be considered acceptable if more than 80% of participants rate the questionnaire items greater than 4 out of 5.
Time frame: 1 Year
Ran from Jul 2024 to primary completion in Oct 2024, 2 months.
Of 1,358 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 71. This study's 2 months is below that.
Counting every sponsor, half of 1,404 studies reached it within 38 months; a quarter within 17 and three quarters within 71.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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